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Zimmer Gmbh recalls Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary
Recalled October 21, 2015 · FDA recall Z-0119-2016 · Zimmer
Hazard
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection. · FDA Class II
Units
57,603 units
Sold at
US Nationwide distribution.
Description
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
Product
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Manufacturer(s)
Zimmer Gmbh
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →